Xolegel

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Xolegel

PATIENT INFORMATION

XOLEGEL®
(Xol-a-gel)
(ketoconazole) Gel, 2%

Read the Patient Information that comes with XOLEGEL
carefully before you start using it and each time you get a refill. There may
be new information. This leaflet does not take the place of talking with your
health care provider. If you have any questions about XOLEGEL, ask your health
care provider.

What is XOLEGEL?

XOLEGEL is a prescription medicine used on the skin to treat
a skin condition called seborrheic dermatitis.

Patients with seborrheic dermatitis can have areas of dry,
flaky skin on the scalp, face, ears, chest, or upper back. XOLEGEL is only to
be used in adults and in children older than 12 years of age who have a normal
(healthy) immune system. XOLEGEL has not been studied in children below the age
of 12.

It is not known whether XOLEGEL can be used to treat fungal
infections.

XOLEGEL is a translucent to clear, amber colored gel.

What should I tell my health care provider before using
XOLEGEL?

Tell your health care provider about all of your medical
conditions, including if you are pregnant or planning to become pregnant, or
are breastfeeding or planning to breastfeed. XOLEGEL should be used during
pregnancy and breastfeeding only if needed.

Tell your health care provider about all of the medicines
you take, including prescription and non-prescription medicines, vitamins, and
herbal supplements. Keep a list of your medicines and show it to your health
care provider and pharmacist. Tell your health care provider and pharmacist
when you get a new medicine. It is not known if XOLEGEL and other medicines can
interact with each other.

How should I use XOLEGEL?

Use XOLEGEL exactly as prescribed. Talk to your health care
provider if your condition gets worse or does not get better by the end of your
treatment.

Wash your hands before and after applying XOLEGEL.

Spread a thin layer of XOLEGEL evenly on the affected skin
with your fingertips. Be sure to cover all affected areas.

Do not wash the areas where you applied XOLEGEL for at least
3 hours after you apply it.

Wait at least 20 minutes after you spread XOLEGEL on your
skin before you put makeup or sunscreens on the affected areas.

Use XOLEGEL once daily for 2 weeks.

What should I avoid while using XOLEGEL?

XOLEGEL is only to be used on the skin. It is not for eye,
mouth, or vaginal use.

Do not touch your eyes, nose, or mouth while you are
applying XOLEGEL. Wash your hands well after you apply it. Irritation may occur
if you get XOLEGEL in your eyes, nose, or mouth.

If used during breastfeeding and XOLEGEL is applied on the
chest, take care to avoid accidental ingestion of XOLEGEL by the baby.

XOLEGEL is flammable (it can catch fire). Stay away from
heat, flame, or smoking while you are applying XOLEGEL and right after you
apply it.

This medication should not be used for any disorder other
than that for which it has been prescribed.

What are the possible side effects of XOLEGEL?

The effects of XOLEGEL during pregnancy, including whether
XOLOGEL can harm your unborn baby, are not known.

It is not known if XOLEGEL can pass into your breastmilk or
if it can harm your breastfed baby.

Stop using XOLEGEL and talk to your health care provider if
you develop itching, a rash, or any skin irritation after using XOLEGEL.

The most common side effect is a burning feeling where
XOLEGEL is applied.

Report any side effects to your health care provider to
receive immediate medical attention. You can also report suspected side effects
by calling the US Food and Drug Administration at 1-800-FDA-1088, or reporting
via the internet at www.fda.gov/medwatch.

These are not all of the side effects
of XOLEGEL. For more information, ask your health care provider or pharmacist.

How should I store XOLEGEL?

Store XOLEGEL at 59°F to 86°F (15° to 30°C).

Keep XOLEGEL and all medicines out of the reach of children.

Contents are flammable. Avoid storing XOLEGEL near heat or
flame.

General information about XOLEGEL

Medicines are sometimes prescribed for conditions that are
not mentioned in Patient Information leaflets. Do not use XOLEGEL for a
condition for which it was not prescribed. Do not give XOLEGEL to other people,
even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most
important information about XOLEGEL. If you would like more information, talk
with your health care provider. You can also ask your pharmacist or health care
provider for information about XOLEGEL that is written for health
professionals.